BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6962336 · Received October 19, 2017

    Report

    Report Number
    2021710-2017-06822
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 25, 2017
    Report Date
    February 5, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON-SITE TO EVALUATE THE SUSPECT DEVICE. THE FSR DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE MAIN PRINTED CIRCUIT BOARD AND TURBINE ASSEMBLY. AFTER REPLACING THE DEFECTIVE PARTS, THE ISSUE WAS RESOLVED. THE FSR REPORTED THE SUSPECTED MAIN PRINTED CIRCUIT BOARD ASSEMBLY AND TURBINE ASSEMBLY ARE AVAILABLE FOR ANALYSIS AND A RETURN GOOD AUTHORIZATION HAS BEEN ISSUED. ONCE A FINAL INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT MAIN PRINTED CIRCUIT BOARD ASSEMBLY FOR INVESTIGATION. AN EVALUATION OF THE COMPONENT COULD BE CONFIRMED AND DUPLICATED. THE COMBINATION OF TRANSDUCER FAULTS AT POWER-UP/AUTO-ZERO WITH THE SUCCESSFUL CALIBRATION OF ALL TRANSDUCERS INDICATES THAT THE AUTO-ZERO SOLENOIDS CAN BE SLOW TO RESPOND. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE USING THE VELA VENTILATOR; THE UNIT DISPLAYS VENTILATOR INOPERABLE AND MOTOR FAULT ALARMS. THE CUSTOMER REPORTED THE ISSUE OCCURRED DURING PRE-USE CHECKS IN THE EQUIPMENT ROOM. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740943 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1